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Research ArticleArticle

Development and Validation of a New Instrument to Measure Health-related Quality of Life in Patients with Psoriatic Arthritis: The VITACORA-19

Juan Carlos Torre-Alonso, Jordi Gratacós, José Santos Rey-Rey, Juan Pablo Valdazo de Diego, Ana Urriticoechea-Arana, Esteban Daudén, Mireia Moreno, Pedro Zarco-Montejo, Eduardo Collantes-Estévez and Juan Antonio Fernández-López
The Journal of Rheumatology October 2014, 41 (10) 2008-2017; DOI: https://doi.org/10.3899/jrheum.131021
Juan Carlos Torre-Alonso
From the Facultad de Medicina; Hospital Monte Naranco, Oviedo; Hospital Parc Tauli, Sabadell; Complejo Hospitalario Toledo, Toledo; Hospital Virgen de la Concha, Zamora; Hospital Can Mises, Ibiza; Hospital Universitario de la Princesa; Hospital Alcorcon, Madrid; University Hospital “Reina Sofía”/IMIBIC, Cordoba; Centro Salud Riosa, Astorias, Spain.
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  • For correspondence: jctorre@telecable.es
Jordi Gratacós
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José Santos Rey-Rey
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Juan Pablo Valdazo de Diego
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Ana Urriticoechea-Arana
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Esteban Daudén
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Mireia Moreno
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Pedro Zarco-Montejo
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Eduardo Collantes-Estévez
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Juan Antonio Fernández-López
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    Figure 1.

    Development and validation process for the VITACORA-19 questionnaire. PsA: psoriatic arthritis.

Tables

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    Table 1.

    Baseline characteristics and health of the study participants (n = 323). Group A: patients with PsA. Group B: patients with arthritis and no psoriatic—any type of arthrosis—any type of dermatitis. Group C: healthy controls.

    CharacteristicsGroup A, n = 209Group B, n = 71Group C, n = 43
    Sociodemographic features
      Age, yrs*, mean (SD)48.7 (11.8)46.5 (15.2)42 (8.2)
      Female*, n (%)89 (42.6)43 (75.7)32 (74.4)
      Educational level*, n (%)
        No education6 (2.9)3 (4.3)0
        Primary education94 (45)34 (48.6)7 (16.4)
        Secondary education72 (34.3)13 (18.6)12 (27.9)
        University studies37 (17.7)20 (28.6)24 (55.8)
        Total209 (100)70 (100)43 (100)
      Employment status*, n (%)
        Working105 (50.5)31 (44.9)40 (93)
        Unemployed16 (7.6)5 (7.3)0
        Student3 (1.4)3 (4.3)0
        Retired46 (22.1)11 (15.9)0
        Housekeeper26 (12.5)16 (23.2)3 (7)
        Other12 (5.8)3 (4.3)0
        Total208 (100)69 (100)43 (100)
    Health assessments
      EQ-5D VAS*, mean (SD)
        VAS (0–100)†65.4 (22.1)65.1 (26.4)91.4 (14.1)
      EQ-5D descriptive system*, %
        Mobility problems44.326.92.5
        Self-care problems28.6270
        Daily activities problems47.819.10
        Pain/discomfort68.656.54.9
        Anxiety/depression5039.10
      Perceived health state*, %
        Good/very good39.145.597.1
      VITACORA-19*, mean (SD)
        Global score‡56.24 (24.8)69.23 (24.8)93.7 (9.1)
    Clinical features
      Time from diagnosis, yrs, mean (SD)8 (7.5)8 (7.7)—
      Psoriasis/other dermatitis diagnosis, n (%)203 (98.5)40 (56.3)—
      Comorbidities, n (%)96 (45.9)30 (43.2)—
      BSA, % (SD)22.4 (28.1)——
      BASDAI, 0–10, mean (SD)2.2 (6.3)——
      DAS28, 2–10, mean (SD)2.7 (1.5)——
    • ↵* p < 0.001.

    • ↵† Range from 0 (worst health status) to 100 (best health status).

    • ↵‡ Global score range from 0 (worst health-related quality of life) to 100 (best health-related quality of life). Statistical significant differences between study groups after adjusting by sociodemographic differences. PsA: psoriatic arthritis; EQ-5D: EuroQol questionnaire 5-Dimensional; VAS: visual analog scale; VITACORA-19: PsA quality of life questionnaire; BSA: body surface area; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; DAS28: 28-joint Disease Activity Score.

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    Table 2.

    Score distributions, floor and ceiling effects, internal consistency, and test-retest reliability of the VITACORA-19 questionnaire.

    VITACORA–19Global Score
    Items, n19
    Mean55.7
    SD24.6
    Theoretical range0–100
    Observed range10.5–100
    Floor*, %0
    Ceiling†, %1
    Cronbach’s alpha0.95
    ICC‡0.94
    • ↵* Percentage of patients with the worst possible score.

    • ↵† Percentage of patients with the best possible score.

    • ↵‡ Stability assessed by patient; subgroup of stable patients, n = 97. VITACORA-19: PsA quality of life questionnaire; ICC: interclass correlation coefficient.

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    Table 3.

    Known-groups validity of VITACORA-19 questionnaire according to groups under study, to subset/clinical/activity features, and to EQ-5D and health state perception scores of patients with PsA at baseline (n = 209). Values given are means ± SD. Higher scores signify better HRQoL. Range from 0 to 100.

    VITACORA-19 Global ScoreANOVA
    Groups under study
      Group A, mean (SD), n = 20956.24 (24.8)p < 0.001
      Group B, mean (SD), n = 7169.23 (24.8)
      Group C, mean (SD), n = 4393.76 (9.1)
      Total, n = 32364.1 (26.6)
      pAll comparisons (Group A–Group B, Group A–Group C, Group B–Group C) were significant at p < 0.001 after adjusting for sociodemographic differences.
    PsA clinical subsets
      Axial, mean (SD), n = 3753.6 (24.1)p = 0.48
      Peripheral, mean (SD), n = 16156.8 (25.1)
        Oligoarthritis, mean (SD), n = 9059.6 (25.1)p = 0.11
        Polyarthritis, mean (SD), n =7153.3 (24.8)
      Total, n = 19856.23 (24.8)
    PsA vs psoriasis
      Psoriatic arthritis, mean (SD), n = 19856.24 (24.8)p < 0.05
      Psoriasis (Group B), mean (SD), n = 1179.96 (30.1)
    PsA disease activity, DAS28 (range 2–10)
      Remission (< 2.6), n = 6271.60 (19.8)p < 0.001
      Moderate disease activity (2.6–5.1), n = 4648.36 (20.6)
      High disease activity (≥ 5.1), n = 1043.41 (19.5)
    EQ-5D descriptive system, mean (SD)
      Mobility problems
        No, n = 11068.2 (20.8)
        Yes, n = 8640.7 (21.1)p < 0.001
        Total, n = 19656.1 (24.9)
      Self-care problems
        No, n = 14364.7 (21.8)
        Yes, n = 5335.7 (14.6)p < 0.001
        Total, n = 19656.4 (24.7)
      Daily activities problems
        No, n = 10571.8 (19.1)
        Yes, n = 9131.8 (13.1)p < 0.001
        Total, n = 19656.2 (24.9)
      Pain/discomfort
        No, n = 6378.9 (17.5)
        Yes, n = 13439.8 (17.6)p < 0.001
        Total, n = 19756.2 (24.9)
      Anxiety/depression
        No, n = 9970.3 (19.4)
        Yes, n = 9838.9 (20.6)p < 0.001
        Total, n = 19756.2 (24.9)
    Perceived health state, mean (SD)
      According to patient
        Good/very good, n = 13265.0 (19)
        Neither good nor bad, n = 1745.9 (23.2)p < 0.001
        Poor/very poor, n = 4930.7 (15.25)
        Total, n = 19856.2 (24.8)
      According to clinician
        Good/very good, n = 11171.6 (14.6)
        Neither good nor bad, n = 3747.2 (19.9)p < 0.001
        Poor/very poor, n = 4730.3 (14.7)
        Total, n = 19556.4 (24.6)
    • VITACORA-19: PsA quality of life questionnaire; EQ-5D: EuroQol questionnaire 5-Dimensional; PsA: psoriatic arthritis; DAS28: 28-joint Disease Activity Score; HRQoL: health-related quality of life.

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    Table 4.

    Convergent validity of VITACORA-19 overall score with EQ-5D VAS, PsA activity assessments, axial night pain intensity, and PsA global activity estimation by clinician and patients.

    Clinical AssessmentsPearson’s rVITACORA–19 Global Score
    EQ-5D (VAS)
      VASr–0.493**
    n197
    PsA activity assessments
      ESRr–0.287**
    n180
      CRPr–0.042
    n183
      BSAr–0.664
    n180
      BASFIr–0.197
    n191
      BASDAIr–0.055
    n39
      DAS-28r–0.423**
    n118
      Axial night pain intensityr0.029
    n195
    PsA global activity
      According to clinicianr0.566**
    n197
      According to patientsr0.234*
    n197
    • ↵* The correlations were statistically significant at p < 0.01.

    • ↵** The correlations were statistically significant at p < 0.001. VITACORA-19: PsA quality of life questionnaire; EQ-5D: EuroQol questionnaire; PsA: psoriatic arthritis; VAS: visual analog scale; ESR: erythrocyte sedimentation rate; CRP: C-reactive protein; BSA: body surface area; BASFI: Bath Ankylosing Spondylitis Function Index; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; DAS28: 28-joint Disease Activity Score.

    • View popup
    Table 5.

    Sensitivity to change over time of the VITACORA-19 questionnaire among patients with PsA according to perceived health state changes.

    Patient’s Perceived Health State ChangesBaseline ChangesChanges at 6 MosChanges
    meanSDnmeanSDnmeanSDnES
    High improvement54.8527.681077.0616.591022.2120.39100.80
    Quite improvement52.1523.793564.7421.453512.5918.94350.53
    Small improvement57.0522.812864.9921.29287.9416.49280.35
    The same61.7024.886266.6622.61624.9615.67620.20
    Small worsening60.2526.271151.6118.8011–8.6417.9611–0.33
    Quite worsening37.0621.09628.0215.836–9.0412.576–0.43
    Global57.1224.6615263.9822.731526.8618.231520.28
    • VITACORA-19: PsA quality of life questionnaire; ES: effect size; PsA: psoriatic arthritis.

    • View popup
    APPENDIX 1.

    Validated version of the VITACORA-19 questionnaire. The following statements refer to how signs and symptoms of psoriatic arthritis could affect your daily life. Your answers will help us to determine your health status, and how your illness affected your ability to perform your daily activities during the last week. There are 5 possible answers following each statement. Please read each statement carefully, answering every question. In case you are not confident, please choose the answer that fits to your reality more accurately. Answers are neither correct nor incorrect. We are just interested in how your illness affects your daily life.

    During the last week, because of your psoriatic arthritis…

    AlwaysVery FrequentlyOccasionally/SometimesRarelyNever
    1.Limited mobility conditioned my life.12345
    2.Takes me a long time to recover from any physical effort.12345
    3.It was difficult to change my position in bed (e.g., roll over).12345
    4.My physical strength diminished.12345
    5.I was unmotivated, not in the mood of doing anything.12345
    6.Due to my exhaustion, I was sad and sorrowful.12345
    7.My mood was affected by illness pain.12345
    8.I was afraid of pain.12345
    9.I was worried about being dependent on third parties because of signs and symptoms.12345
    10.I felt desperate because of symptoms’ pain.12345
    11.I avoid meeting people. I can’t keep up their pace.12345
    12.My usual work/non–employment activities (including housework) performance went down.12345
    13.I was afraid of lose my job after asking for a sick leave.12345
    14.People shun me because of my skin appearance.12345
    15.I had difficulties doing some manual activities (e.g., grab something, driving, cooking, use computer…).12345
    16.My pain woke me up in the middle of the night, not allowing me to rest.12345
    17.Pain affected me the most.12345
    18.Inflammation and joint discomfort (e.g., ankle, knee, wrist, fingers…) affected me the most.12345
    19.I was worried about the future evolution of my illness (e.g., needing a cane or crutches…).12345
    • This version in English of the VITACORA-19 questionnaire is provided only to give readers an idea of questionnaire content. It is not an official adapted version, and should not be used in any type of study or in clinical practice. Anyone wishing to use the VITACORA-19 questionnaire should contact the corresponding author.

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Development and Validation of a New Instrument to Measure Health-related Quality of Life in Patients with Psoriatic Arthritis: The VITACORA-19
Juan Carlos Torre-Alonso, Jordi Gratacós, José Santos Rey-Rey, Juan Pablo Valdazo de Diego, Ana Urriticoechea-Arana, Esteban Daudén, Mireia Moreno, Pedro Zarco-Montejo, Eduardo Collantes-Estévez, Juan Antonio Fernández-López
The Journal of Rheumatology Oct 2014, 41 (10) 2008-2017; DOI: 10.3899/jrheum.131021

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Development and Validation of a New Instrument to Measure Health-related Quality of Life in Patients with Psoriatic Arthritis: The VITACORA-19
Juan Carlos Torre-Alonso, Jordi Gratacós, José Santos Rey-Rey, Juan Pablo Valdazo de Diego, Ana Urriticoechea-Arana, Esteban Daudén, Mireia Moreno, Pedro Zarco-Montejo, Eduardo Collantes-Estévez, Juan Antonio Fernández-López
The Journal of Rheumatology Oct 2014, 41 (10) 2008-2017; DOI: 10.3899/jrheum.131021
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Keywords

PSORIATIC ARTHRITIS
HEALTH-RELATED QUALITY OF LIFE
QUESTIONNAIRES
VALIDATION

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